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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wound Dressing With Animal-Derived Material(S)
510(k) Number K260532
Device Name Derma-Gide
Applicant
Geistlich Pharma AG
Bahnhofstrasse 40
Wolhusen,  CH 6110
Applicant Contact Erik Wirth
Correspondent
QUARAS, LLC
2101 Camino Rey
Fullerton,  CA  92833
Correspondent Contact Roshana Ahmed
Classification Product Code
KGN  
Date Received02/17/2026
Decision Date 03/19/2026
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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